Rib Fracture Cryoanalgesia

March 19, 2026 updated by: Methodist Health System
Rib fractures lead to poor patient outcomes and even death 3. Data suggests effective pain management is crucial to obtain favorable outcomes 4, 5Current outpatient treatment modalities are limited to oral or topical medications with low efficacy and high risk for opioid dependence. In-patient management with a thoracic epidural TEA is largely considered the gold standard, but the risks of TEA may outweigh the benefits 6 to 8.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methodist Dallas Medical Center MDMC is an urban Level I Trauma Center that manages over 200 rib fracture cases annually. MDMC has a history of developing and using innovative analgesia techniques aimed at improving outcomes. In 2010 we first described the need for advancements in the treatment of rib fracture patients 1. Later, we validated the technique that is now used at hundreds of trauma centers around the world 2. Our surgical and research teams have a history of advocating for optimal management of rib fracture pain in order to prevent serious complications.

This study will seek to describe the effective use of cryoanalgesia as a feasible method of pain management in the rib fracture patient. With a small cohort and case series, we will describe and refine the procedure and preliminary efficacy of the FDA-approved iovera system in adult rib fracture patients. In order to ethically assess the clinical relevance of the iovera system, our objective will be accomplished by completing a case series

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

≥18 years of age Acute pain attributed to rib fracture(s) Able to obtain consent

Description

Inclusion Criteria:

  • 18 years of age Acute pain attributed to rib fracture(s) Able to obtain consent

Exclusion Criteria:

  • <18 years of age Pregnant Incarcerated Confounding injuries or significant pain attributed to secondary injury Patients with any of the following: cryoglobulinemia; paroxysmal cold hemoglobinuria; cold urticarial; Raynaud's disease; open and/or infected wounds at or near the treatment site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case Series
Prospective: Case Series The investigators will complete ioveraº system training (i.e., cadaveric demonstration) and work with our local surgical team to develop an effective procedure. The technique will then be refined and considered fully developed with three consecutive successful placements. Data reporting to the sponsor will occur once data for the first five successful interventions and the subsequent 14-day follow-ups are completed. Adverse event reporting to the IRB will occur in accordance with GCP standards. Due to the small sample size and short duration, patients lost to follow-up will be an indication for additional enrollment. No more than 10 total subjects will be enrolled.
Device: ioveraº system
the use of surgical procedure that produces lesions in peripheral nervous tissue through application of extreme cold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessment
Time Frame: 14 days
Pain assessment using the Numeric Rating Scale for Pain NRS Pain McGill Pain Questionnaire [MPQ]), hospital LOS, ICU LOS, ventilator days, pain interference (using the Brief Pain Inventory [BPI]), sleep interference (using the Medical Outcomes Sleep Scale [MOS-Sleep]), sleep quality (using the Pittsburgh Sleep Quality Index [PSQI]), quality of life assessment [14], adverse events, re-admissions, and patient satisfaction [15].
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: 30 days
Demographics age, sex, ethnicity, injury characteristics injury severity score ISS, abbreviated injury scale [AIS], mechanism, cause of injury), comorbidities, diagnoses, procedures, Glasgow Coma Scale (GCS) score (eye, verbal, motor, total), discharge status, discharge condition, emergency department and admission vitals, medication
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Collaborators

Pacira Pharmaceuticals, Inc

Investigators

  • Principal Investigator: Conner McDaniel, MD, Methodist Heath System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2023

Primary Completion (Actual)

June 12, 2025

Study Completion (Actual)

June 12, 2025

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 057.GME.2021.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual. Data will be shared with the sponsor after all identifiers are removed and a data use agreement fully executed prior to dissemination of any data.

IPD Sharing Time Frame

All study-related documents will be retained by the CRI until at least three years after study completion or according to local laws, whichever is longer.

IPD Sharing Access Criteria

ClinicalTrials.gov

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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